Drug application

GATIFLOXACIN (GATIFLOXACIN)

Drugs@FDA ANDA 204227 · SANDOZ

Key facts

Drug name GATIFLOXACIN
Active ingredients GATIFLOXACIN
Application type ANDA
Application number 204227
Company SANDOZ
Dosage forms SOLUTION/DROPS, OPHTHALMIC
Strength 0.5%
Marketing status Prescription
TE codes AT
Reference listed drug No
Latest submission status date Jul 11, 2016

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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